EP3095392B1 - Emballage pour sutures - Google Patents
Emballage pour sutures Download PDFInfo
- Publication number
- EP3095392B1 EP3095392B1 EP15001478.5A EP15001478A EP3095392B1 EP 3095392 B1 EP3095392 B1 EP 3095392B1 EP 15001478 A EP15001478 A EP 15001478A EP 3095392 B1 EP3095392 B1 EP 3095392B1
- Authority
- EP
- European Patent Office
- Prior art keywords
- suture
- package
- cover member
- base member
- needle
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
- 238000004804 winding Methods 0.000 claims description 36
- 230000001954 sterilising effect Effects 0.000 claims description 5
- 238000004659 sterilization and disinfection Methods 0.000 claims description 5
- 230000000844 anti-bacterial effect Effects 0.000 claims description 2
- 239000000463 material Substances 0.000 description 3
- 238000000034 method Methods 0.000 description 3
- 230000000845 anti-microbial effect Effects 0.000 description 2
- 239000011248 coating agent Substances 0.000 description 2
- 238000000576 coating method Methods 0.000 description 2
- 230000014759 maintenance of location Effects 0.000 description 2
- 238000004806 packaging method and process Methods 0.000 description 2
- 238000012858 packaging process Methods 0.000 description 2
- 239000000123 paper Substances 0.000 description 2
- 239000004033 plastic Substances 0.000 description 2
- 229920003023 plastic Polymers 0.000 description 2
- -1 polyethylene Polymers 0.000 description 2
- 238000001356 surgical procedure Methods 0.000 description 2
- 239000004677 Nylon Substances 0.000 description 1
- 239000004698 Polyethylene Substances 0.000 description 1
- 239000004743 Polypropylene Substances 0.000 description 1
- 241001422033 Thestylus Species 0.000 description 1
- 230000000712 assembly Effects 0.000 description 1
- 238000000429 assembly Methods 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 230000018109 developmental process Effects 0.000 description 1
- 239000006260 foam Substances 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 230000013011 mating Effects 0.000 description 1
- 229920001778 nylon Polymers 0.000 description 1
- 239000011087 paperboard Substances 0.000 description 1
- 229920000728 polyester Polymers 0.000 description 1
- 229920000573 polyethylene Polymers 0.000 description 1
- 229920000098 polyolefin Polymers 0.000 description 1
- 229920001155 polypropylene Polymers 0.000 description 1
- 230000005855 radiation Effects 0.000 description 1
- 230000001429 stepping effect Effects 0.000 description 1
- 238000003856 thermoforming Methods 0.000 description 1
- 239000012815 thermoplastic material Substances 0.000 description 1
- 238000011282 treatment Methods 0.000 description 1
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
- A61B17/06114—Packages or dispensers for needles or sutures
- A61B17/06133—Packages or dispensers for needles or sutures of parallelepipedal shape, e.g. made of rectangular or slightly oval panels
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
- A61B17/06114—Packages or dispensers for needles or sutures
- A61B2017/06142—Packages or dispensers for needles or sutures having needle- or suture- retaining members, e.g. holding tabs or needle parks
Definitions
- This invention relates to packages for surgical sutures.
- Conventional surgical suture and needle packages serve several useful functions, including protecting the needles and sutures during handling, shipping, and storage.
- the packages facilitate access and release of the needles and sutures during surgery or other medical procedures prior to application.
- the packages may be used for surgical sutures armed with surgical needles or for unarmed surgical sutures without needles.
- Packaging for surgical sutures with or without needles is well known in the art.
- One type of package is a paper folder package wherein a medical grade paperboard is folded and cut into a plurality of panels. The suture is then wound onto a panel, and the package is then assembled by first folding the panels into a desired configuration, and then locking the panels in place using slits and locking tabs which have been cut into the panels.
- suture package Another type of suture package which has been used is a tray package having a winding channel. These tray packages typically have an oval shape with outer and inner walls forming an oval winding channel. The packages are typically molded from plastics. The packages are mounted onto a winding fixture and sutures are then wound into the winding channel. Suture packages typically have a needle park member for mounting and securing a surgical needle if a surgical needle is mounted to the sutures. Conventional needle parks can consist of foam members, or equivalent retention structures. The needle park members can also be utilized for mounting one end of a suture wound into the winding channel.
- U.S. Patent No. 4,961,498 discloses a two-piece suture package having an oval winding channel.
- U.S. Patent No. 4,967,902 discloses a one-piece channel suture package having a plurality of door members which retain the suture in the channel.
- U.S. Patent No. 5,230,424 discloses a package having a substantially square shape and having a square shaped suture channel wherein a plurality of cantilevered doors are mounted to an inner wall to maintain sutures in the channel.
- U.S. Patent No. 5,655,652 discloses a package having an oval-shaped winding channel with a top friction plate member in lieu of doors or cantilevered doors.
- U.S. Patent No. 5,131,533 discloses a needle park having a hinged section.
- U.S. Patent No. 5,180,053 discloses a suture package having a cantilevered arm needle park. This park extends vertical to the base of the package. This type of park has the disadvantage of allowing the needle to release if the package is flexed during transportation.
- U.S. Patent No. 6,135,272 discloses a plurality of cantilevered cover door members with spaces in between. These door members have a disadvantage of deforming if the stylus is moving at a high speed therefore limiting the winding speed.
- WO 2013/049400 A1 discloses a suture package having two halves.
- the interior of the body portion is provided with a pair of posts in one half of the body portion and a corresponding pair of mating bosses in the other half of the body portion.
- the posts fit into the bosses in a press fit or snap fit manner to secure the two halves together.
- the posts and bosses also provide a structure around which the suture strands may be wrapped.
- EP 2 172 157 A1 discloses a suture package for retaining a barbed suture including a suture retaining member with an outer wall and an inner wall.
- the inner wall is radially spaced from the outer wall and defines a suture retaining area therebetween.
- the outer wall includes a plurality of inwardly extending tabs configured to engage a cover.
- the suture package further includes a cover configured to be received within the outer wall of the suture retaining member and to selectivly engage the inwardly extending tabs formed thereon.
- suture tray packages of the prior art are adequate and effective for their intended use, there are disadvantages associated with such packages.
- An example of one type of problem which may occur is suture "hang-up" when the surgeon attempts to withdraw the suture from the package.
- suture tray packages having winding channels which are readily adaptable to high-speed packaging processes which overcome the disadvantages of the prior art packages, including problems associated with suture withdrawal.
- gasses to be able to flow easily around the sutures to facilitate sterilization and antimicrobial coating.
- suture package according to the invention is produced by the features of the main claim. Appropriate developments of the invention are subject matter of further claims following the main claim.
- a suture package has a base member having a top surface, a bottom surface, an outer periphery and a longitudinal axis.
- An outer wall extends upwardly about the periphery of said base member, said outer wall having an inner surface, an outer surface, and a top.
- An inner plurality of cylindrical standoff members is arranged in an oval shape that defines and captures the suture therefore forming a channel for the suture to lie in. These standoff members have an interference fit snap that allows the cover member to be secured.
- the suture channel cover member for mounting to the base member.
- the suture channel cover member has a top surface, a bottom surface and an outer periphery.
- a plurality of fastener holes exists in the cover member.
- a port exit opening having a first end and a second end is located in the outer track wall and forms a suture port.
- a suture park member extends up from the base member to the bottom surface of the cover member.
- a slit in the base member interior to the outer wall forms the tab lifting member.
- the cover member is mounted to the base member to form the package of the present invention by aligning the cover member fastener holes with the base member standoff members and inserting the interference fit snaps of the base member into the holes in the cover.
- This forms a suture channel between the inner surface of the outer wall of the base member, the top surface of the base member, the outer side of the standoff members and the bottom surface of the suture cover member.
- An optional plastic top suture cover may be utilized to complete assembled package. This assembly is completed after the suture is wound into the channel formed by the cover top, the base outer wall, the base top surface and the suture winding pins.
- the package 10 of the present invention is illustrated in Figs. 1 to 10 .
- the package 10 has a base member 30 and a suture channel cover member 200.
- the base member 30 is seen to have a top surface 31 and a bottom surface 32.
- the base member 30 is also seen to have an outer periphery 35.
- the base member 30 is seen to be a substantially flat and substantially oval shaped member having a longitudinal axis 34.
- the base member 30 along with the package 10 be oval shaped, other configurations can be used including circular, polygonal, square with rounded corners, and the like and combinations thereof and equivalents thereof.
- Outer wall 40 Extending upwardly about the periphery 35 of the base member 30 is an outer wall 40.
- Outer wall 40 is seen to have a bottom, an inner surface 42, an outer surface 43 and a top 44.
- the standoff members 60 are seen to extend upward from the top surface 31 of the base member 30.
- the standoff members 60 have flat tops 62. These flat tops 62 have an interference fit snap 64 for the attachment of the cover member 200.
- the shape of the snap 64 is shown in its preferred configuration. Alternatively, the snap can have a geometric shape, or any shape that provides an interference fit.
- the tops of the snaps 64 are preferably below the top 44 of the outer wall 40.
- the standoff members 60 are seen to preferably have a cylindrical surface 66, but they may also have flat outer surfaces. If desired, the standoff members 60 may have other configurations for outer surfaces including semi-circular, polygonal, oval, triangular, or combinations thereof and equivalents thereof and the like. A combination of standoff members 60 with flat and with curved outer surfaces are also possible.
- the cover locks 70 have a top 71, a bottom, a right side and a left side.
- the cover locks 70 hold the cover member 200 in place after winding is complete.
- a plurality of air slots 110 Extending through the bottom of the base member 30 are a plurality of air slots 110 (see Fig. 4 ). Also extending through the bottom of the base member 30 are the circular winding drive pin locating hole 120 and the oval drive pin locating hole 125. The holes 120 and 125 are seen to be disposed along the longitudinal axis 34 and are at opposite ends of the base member 30. The lifting tab 150 is seen to be located in the base member 30 toward the circular locating hole 120.
- the suture channel cover 200 has a top surface 201, a bottom surface 202 and a periphery 204.
- the pin winding holes 250 and 255 are seen to be contained at opposite ends of the cover member 200.
- Pin winding holes 250, 255 are seen to extend through the cover member 200 and to be disposed in the cover member 200 along its longitudinal axis 203, toward either end, and are further seen to line up with winding drive pin holes 120 and 125 in the base member 30.
- Pin winding holes 250 and 255 are seen to be circular in shape. However, other geometric shapes can be utilized.
- the suture exit port 260 is seen to be contained in the cover member 200. Also seen to extend through the cover member 200 are the cover snap mounting holes 300 that mate up with the standoff members 60 of the base member 30. The diameter and shape is determined by the type of interference fit and the style of the snaps 64.
- suture winding pin holes 310 that extend through the cover member 200.
- the preferred shape is oval but other shapes can be utilized such as round, octagonal, semi-circular, polygonal, triangular, combinations thereof and equivalents thereof and the like.
- the needle park in Fig. 7 is shown in its preferred configuration with two horizontal cantilevered members 350.
- Each member 350 has a V-shaped notch 354 that leaves a small land to contact the needle 550 and hold it in place. This land then deforms during the winding process due to pressure from the winding head creating a hold area 353.
- Fig. 7 shows two needle park areas, a large one 352 and a small one 351. It is understood that there can be more than two steppings from largest to smallest needle front to back.
- the packages 10 of the present invention are assembled in the following manner.
- the base member 30 is mounted into a conventional, rotatable winding fixture, such that the winding pins 311 of the winding fixture are inserted through the winding drive pin openings 125 and 120.
- the needle 550 is placed into the needle park members 350.
- the suture 500 is threaded out of port 260 into the channel 11.
- the suture channel cover 200 is printed by conventional means and pin winding holes 250 and 255 of the suture cover member 200 are aligned with winding drive openings 125 and 120 of the base member 30.
- the suture cover 200 is then brought down so that the bottom surface 202 is less than one millimeter above the top 44 of the outer wall 40 of the base member 30.
- the suture winding pins 311 in the winding now come through the holes 310 in the suture cover member 200 and rest on the top surface 31 of the base member 30. This forms a suture channel for winding formed by the top surface 31 of the base member 30, the suture winding pins 311, and the bottom surface 202 of the cover member 200. This creates a small gap for the suture 500 to enter the track area 11.
- the suture cover 200 can be brought down and the interference fit snaps 64 are pushed through the interference fit holes 300 in the suture cover member 200 until the flat tops 62 of the standoff members 60 contact the bottom surface 202 of the suture cover 200 and held in place by the winding head.
- the bottom surface 202 of the suture cover 200 should be left in contact with the top 71 of the outer cover locks 70 allowing the suture cover 200 to be lifted to wind the suture 500 into the suture track 11.
- the suture 500 is guided into the package 10 by a conventional stylus which lifts the cover member 200 or runs between the suture cover 200 and the top 44 of the outer wall 40 of the base member.
- Package 10 is rotated in the fixture such that the suture 500 is completely wound in the suture track 11 as the package is rotated. This may be repeated with additional sutures 500 and needles 550.
- the suture cover 200 is pushed into the fully locked position, where the top surface 201 of the cover member 200 is in contact with the bottom of the outer cover locks 70 and the interference fit snaps 64 are pushed through the interference fit holes 300 in the cover member 200.
- the package 10 containing the wound sutures 500 and needles 550 may then be placed in a conventional pouch or package for conventional sterilization treatments such as gaseous sterilants, autoclaving, radiation and the like.
- This invention will allow for high speed winding due to its capability to be wound before the cover member 200 is locked in place.
- the package 10 When used by the physician in a surgical procedure, the package 10 is placed into a sterile field. Using a conventional needle grasper, the surgeon pushes down lifting tab 150 and the needle 550 is grasped and removed from the needle park members 350. The needle 550 and the suture 500 are then pulled away from the package 10 and suture 500 exits through exit port 260 and channel exit and then from channel 11.
- the packages 10 of the present invention may be manufactured from conventional moldable materials. It is especially preferred to use polyolefin materials such as polyethylene and polypropylene, other thermoplastic materials, and polyester materials such as nylon, and equivalents thereof. Preferably the packages 10 of the present invention are injection molded, however, the packages 10 may be formed by other conventional processes and equivalents thereof including thermo-forming. If desired, the packages 10 may be manufactured as individual assemblies or components which are then assembled.
- polyolefin materials such as polyethylene and polypropylene, other thermoplastic materials, and polyester materials such as nylon, and equivalents thereof.
- the packages 10 of the present invention are injection molded, however, the packages 10 may be formed by other conventional processes and equivalents thereof including thermo-forming. If desired, the packages 10 may be manufactured as individual assemblies or components which are then assembled.
- the sutures 500 and needles 550 that can be packaged in the packages 10 of the present invention include conventional surgical needles and conventional bioabsorbable and nonabsorbable surgical sutures and equivalents thereof.
- the packages 10 of the present invention are useful to package small diameter sutures which were previously difficult to package in tray packages because of removal or hang-up problems upon withdrawal of such suture from the packages. These problems have been overcome using the packages 10 of the present invention.
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- Health & Medical Sciences (AREA)
- Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Biomedical Technology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Engineering & Computer Science (AREA)
- Dentistry (AREA)
- Heart & Thoracic Surgery (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Surgical Instruments (AREA)
Claims (9)
- Emballage (10) pour des sutures chirurgicales (500), comprenant
un élément de base (30) présentant une surface supérieure (31), une surface inférieure (32), une périphérie extérieure (35) et un axe longitudinal (34),
une paroi extérieure (40) qui s'étend vers le haut à partir de la périphérie (35) dudit élément de base (30), ladite paroi extérieure (40) présentant une surface intérieure (42), une surface extérieure (43), et un sommet (44),
une pluralité d'éléments de verrouillage (70) qui s'étendent vers l'intérieur à partir de la surface intérieure (42) de la paroi extérieure (40), chaque élément de verrouillage (70) présentant un sommet (71), un pied et une surface extérieure,
une pluralité d'éléments de picot cylindriques (60) disposés en une forme ovale qui définit et capture la suture (500), lesdits éléments de picot (60) s'étendant à partir de la surface intérieure de l'élément de base (30), chaque élément de picot (60) présentant un sommet (62), un pied et une surface extérieure (66), lesdits éléments de picot (60) en conjonction les uns avec les autres formant une piste de suture pour retenir la suture (500),
un élément de recouvrement de canal de suture (200) présentant une surface supérieure (201), une surface inférieure (202) et une périphérie extérieure (204),
une ouverture (260) dans le bord extérieur de l'élément de recouvrement (200) formant un port de suture présentant une première extrémité et une seconde extrémité,
des moyens de rangement d'aiguille (350) situés à l'intérieur des éléments de picot cylindriques (60) et qui s'étendent à partir de la surface supérieure (31) de l'élément de base (30) pour retenir une aiguille chirurgicale (550),
caractérisé en ce que ledit emballage (10) comprend:une pluralité de fermoirs profilés (64) pour accepter l'élément de recouvrement (200), chaque fermoir profilé (64) étant placé sur le sommet (62) d'un élément de picot (60),ledit élément de recouvrement (200) comportant une pluralité de trous de précision (300) qui s'étendent à travers l'élément de recouvrement (200) afin de verrouiller ledit élément de recouvrement (200) sur les fermoirs profilés (64) des éléments de picot (60) en poussant les fermoirs profilés (64) à travers les trous de précision (300) dans l'élément de recouvrement (200) jusqu'à ce que le sommet (62) d'un élément de picot (60) soit en contact avec la surface inférieure (202) de l'élément de recouvrement (200) et que la base du fermoir profilé (64) soit en contact avec la surface supérieure (201) de l'élément de recouvrement (200). - Emballage selon la revendication 1, comportant en outre des trous (250, 255) à travers l'élément de recouvrement (200) destinés à recevoir des broches d'enroulement.
- Emballage selon la revendication 1 ou 2, comportant en outre une pluralité de fentes d'aération (110) dans une région de piste de suture (11) de l'élément de base (30).
- Emballage selon l'une quelconque des revendications précédentes, comprenant en outre:une suture (500) enroulée dans un canal d'enroulement (11), etune aiguille chirurgicale (550) montée dans les moyens de rangement d'aiguille (350).
- Emballage selon l'une quelconque des revendications précédentes, dans lequel les fermoirs profilés (64) sont ajustés par pression ou déformés thermiquement à travers l'élément de recouvrement (200).
- Emballage selon l'une quelconque des revendications précédentes, dans lequel l'emballage (10) présente une configuration ovale.
- Emballage selon l'une quelconque des revendications précédentes dans lequel
l'élément de rangement d'aiguille comprend un élément horizontal (350), qui présente de multiples élévations (351, 352) à partir de la surface supérieure (31) de l'élément de base (30), et
le pied de l'élément horizontal (350) est au moins partiellement situé au-dessus d'une ouverture (150) dans l'élément de base (30). - Emballage selon la revendication 7, dans lequel le pied de l'élément de rangement horizontal (350) présente des parois verticales minces destinées à permettre une déformation après qu'une aiguille (550) ait été rangée de manière à réaliser le verrouillage de l'aiguille (550).
- Emballage selon l'une quelconque des revendications précédentes, présentant une paroi intérieure ouverte au niveau de la piste de suture formée par les éléments de picot cylindriques (60) qui permet qu'un gaz de stérilisation/antibactérien puisse circuler librement autour de la suture.
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP15001478.5A EP3095392B1 (fr) | 2015-05-18 | 2015-05-18 | Emballage pour sutures |
ES15001478.5T ES2656274T3 (es) | 2015-05-18 | 2015-05-18 | Envase para suturas |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP15001478.5A EP3095392B1 (fr) | 2015-05-18 | 2015-05-18 | Emballage pour sutures |
Publications (2)
Publication Number | Publication Date |
---|---|
EP3095392A1 EP3095392A1 (fr) | 2016-11-23 |
EP3095392B1 true EP3095392B1 (fr) | 2017-11-01 |
Family
ID=53180495
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP15001478.5A Active EP3095392B1 (fr) | 2015-05-18 | 2015-05-18 | Emballage pour sutures |
Country Status (2)
Country | Link |
---|---|
EP (1) | EP3095392B1 (fr) |
ES (1) | ES2656274T3 (fr) |
Families Citing this family (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US10835237B2 (en) | 2017-04-24 | 2020-11-17 | Ds-Technology Gmbh | Package for sutures |
EP3501402B1 (fr) | 2017-12-19 | 2020-06-17 | DS-Technology GmbH | Emballage pour sutures et aiguilles |
Family Cites Families (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4961498A (en) | 1988-08-24 | 1990-10-09 | Ethicon, Inc. | Oval wrap suture package |
US4967902A (en) | 1989-09-12 | 1990-11-06 | Ethicon, Inc. | One piece channel suture packages |
US5131533A (en) | 1991-08-28 | 1992-07-21 | Ethicon, Inc. | Needle park |
US5180053A (en) | 1992-02-28 | 1993-01-19 | Ethicon, Inc. | Cantilevered needle park |
US5230424A (en) | 1992-06-19 | 1993-07-27 | Ethicon, Inc. | Multi-strand suture package and cover-latching element |
JP3226752B2 (ja) | 1995-04-12 | 2001-11-05 | 株式会社東芝 | 半導体装置の製造方法 |
US6135272A (en) | 1999-10-22 | 2000-10-24 | Ethicon, Inc. | Package for sutures |
US9622743B2 (en) * | 2008-10-02 | 2017-04-18 | Covidien Lp | Suture packaging |
WO2013049400A1 (fr) * | 2011-09-27 | 2013-04-04 | Curax, Llc | Système de mise en place de sutures |
GB2514994A (en) * | 2013-04-05 | 2014-12-17 | Sutures Ltd | Suture packages |
-
2015
- 2015-05-18 ES ES15001478.5T patent/ES2656274T3/es active Active
- 2015-05-18 EP EP15001478.5A patent/EP3095392B1/fr active Active
Non-Patent Citations (1)
Title |
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None * |
Also Published As
Publication number | Publication date |
---|---|
EP3095392A1 (fr) | 2016-11-23 |
ES2656274T3 (es) | 2018-02-26 |
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